Journal of Clinical and Aesthetic Dermatology

MauiDerm 2017

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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S11 JCAD journal of clinical and aesthetic dermatology May 2017 • Volume 10 • Number 5 (Supplement 1) c urrently limited. The efficacy and s afety of DRM04, a cholinergic receptor antagonist developed for topical treatment of primary axillary hyperhidrosis, was assessed in two Phase 3 trials. Methods: ATMOS-1 (NCT02530281) and ATMOS-2 (NCT02530294) were d ouble-blind, vehicle (VEH)-controlled, randomized, four-week (wk) trials. Eligible pts, aged ≥9 years, had primary axillary hyperhidrosis of ≥6 months duration: sweat production of ≥50 mg/5 min in each axilla, measured gravimetrically; an Axillary Sweating Daily Diary (ASDD) score ≥4 (on an 11- point scale); and a Hyperhidrosis Disease Severity Scale (HDSS) grade 3 or 4. Pts were randomized 2:1 to DRM04 3.75% or VEH, applied once daily to both axillae. The co-primary efficacy endpoints were ASDD response (≥4-point improvement) and mean absolute change in axillary sweat production (average of both axillae) at Week 4. MCMC multiple imputation was used to impute missing values in the ITT population. Significance calculations were performed versus the VEH groups using Cochran-Mantel- Haenszel test (ASDD response) and ANCOVA model (axillary sweat production). Results: 344 (ATMOS-1) and 353 (ATMOS-2) pts were randomized. More DRM04-treated pts reported an ASDD response compared to VEH groups (ATMOS-1: Week 2: 47.1% vs. 19.9%; Week 4: 52.8% vs. 28.3%, p<0.001; ATMOS-2: Week 2: 53.8% vs. 18.1%; Week 4: 66.1% vs. 26.9%, p< 0.001). Differences in the mean absolute change in sweat production from baseline, in DRM04 versus VEH groups, were observed from Week 2 (ATMOS-1: Week 2: -85.7 vs. -71.5 mg/5 min; Week 4: -96.2 vs. -90.6 mg/5 min, [p=0.001: pre-specified sensitivity analysis e xcluding extreme outliers], -104.9 vs. - 9 1.9 mg/5 min [p=0.065: ITT population including extreme outlier data]; ATMOS-2: Week 2: -111.4 vs. -86.0 mg/5 min; Week 4: -110.3 vs. -92.2 mg/5 min, p< 0.001). Adverse events (AEs) occurred in 54.2 and 57.8 percent of DRM04 pts, and 28.9 and 35.6 percent o f VEH pts, in ATMOS-1 and ATMOS-2, respectively. The majority of DRM04-pt AEs were related to anticholinergic activity and were mild, transitory, and rarely led to study discontinuation. Conclusion: Topically applied DRM04 demonstrated clinically meaningful improvements in disease severity and sweat production from Week 2 onwards. Daily application of DRM04 over a four-week treatment period was well-tolerated. Financial diclosures/funding: These studies were funded by Dermira, Inc. Medical writing support was provided by Costello Medical Consulting Limited (Cambridge, UK) and Prescott Medical Communications Group (Chicago, IL). All costs associated with development of this abstract were funded by Dermira, Inc. PHOTODAMAGE Evaluation of a Double Conjugate Retinoid Cream vs. Retinol or Tretinoin Cream in Subjects with Photodamage Presenters: David H. McDaniel, 1 Chris Mazur, 1 Diane B. Nelson, 2 Mitch Wortzman 2 Affiliations: 1 McDaniel Institute of Anti-Aging Research; 2 Skinbetter Science, LLC Synopsis: Photodamage is associated with premature skin aging. Topical retinoids are an effective treatment option. However, irritation reactions limit their utility. Herein, we describe use of a double conjugate r etinoid cream comprising the p roperties of both a retinoid and lactic acid. Objective: To evaluate the effectiveness and tolerability of a double conjugate retinoid cream (AHA- Ret) in photoaging vs. 1.0% retinol or 0.025% tretinoin. M ethods: A 12-week, split-face trial was conducted in 48 females, 30 to 65 years of age with mild-to-severe photodamage. Subjects randomly applied AHA-Ret to one side of their face (n=48), and 1.0% retinol (n=24) or 0.025% tretinoin (n=24) to the opposite side (PM). Evaluation of images by an expert-grader, hydration (NOVA meter), and completion of a 21-question self- assessment occurred at baseline, 4, 8, and 12 weeks. Tolerability was assessed throughout. Results: Forty-seven subjects completed the study; one subject was lost to follow-up; average age was 55 years. AHA-Ret demonstrated significant reductions from baseline in average severity of dyschromia, fine lines, and skin tone degradation at 4 weeks (p<0.0001). Reductions in average severity were demonstrated with AHA-Ret at 8 and 12 weeks, respectively, compared to baseline: fine lines (p<0.0001, p<0.0001), erythema (p<0.004, p<0.001), dyschromia (p<0.0001, p<0.0001), skin tone (p<0.0001, p<0.0001), and pore size (p<0.035, p<0.0001). AHA-Ret induced significantly less erythema vs. retinol at 8 and 12 weeks (p<0.007 and p<0.02). Significant reductions in pore size occurred with AHA-Ret and tretinoin at 8 (p<0.03, p<0.02) and 12 weeks (p<0.0001, p<0.0001), respectively. AHA-Ret was noninferior to tretinoin for fine lines, erythema, dyschromia, and skin tone. Significant improvement in hydration occurred only with AHA- Ret at 4, 8, and 12 weeks (p<0.04,

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